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Clinical Trials/NCT05960682
NCT05960682
Completed
Not Applicable

French Translation and Validation of the Brief Index of Sexual Functioning for Men

University Hospital, Toulouse1 site in 1 country14 target enrollmentJuly 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sexual Dysfunction Male
Sponsor
University Hospital, Toulouse
Enrollment
14
Locations
1
Primary Endpoint
Response rate to the paper questionnaire
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

Sexual dysfunction consists of a disorder of the sexual response, either in terms of desire, or in terms of vasocongestion, or in terms of orgasmic response, or in more than one phase of this response :

Sexual dysfunctions are today described by the Diagnostic and Statistical Manual (DSM) V as:

  • Disorders of sexual desire or decreased libido
  • Sexual arousal disorder
  • Delayed or absent orgasmic disorder
  • Sexual disorder with pain Moreover, sexual dysfunctions are not without consequences on the life of a couple. The origins of these dysfunctions are multiple, but the result is most of the time the same: fear of failure, feeling of incompetence, anxiety, frustration or misunderstanding.

To date, the scientific community benefits from a few self-administered questionnaires to measure the impact of certain dysfunctions. None takes into account all the dimensions of male sexuality. In Italy, the Brief Index of Sexual Functioning for Men is used. This questionnaire contains 22 items, grouped into 7 areas exploring all of male sexuality: desire, arousal, frequency of activity, receptivity, pleasure/orgasm, relationship satisfaction, problem affecting sexuality. This questionnaire is not currently validated in French, whereas the Brief Index of Sexual Functioning for Women is validated.

Detailed Description

In this context, the Andrology Committee of the French Association of Urology wishes to create a pilot study with French patients presenting sexual dysfunctions with the aim of validating the questionnaire in French. Patient responses to each item will: * to determine if the formulation of the items is understandable by all, or if this is not the case * to identify the difficulties it can cause, and their causes. Patients treated for sexual dysfunction will be informed of the possibility of answering a questionnaire and that their data will be recorded for the purpose of studying practices and analyzing the results in an anonymous setting, and confidential via the delivery of the information leaflet dedicated to the study. They will have the opportunity to signify their refusal to participate without risk of modification of the coverage.

Registry
clinicaltrials.gov
Start Date
July 15, 2023
End Date
July 15, 2024
Last Updated
4 months ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patient with sexual dysfunction

Exclusion Criteria

  • Patient refusing to participate
  • Patient with difficulties in understanding the French language.
  • Protected persons referred to in Articles L.1121-6 to L.1121-8 of the Public Health Code

Outcomes

Primary Outcomes

Response rate to the paper questionnaire

Time Frame: Day 1

Answer two sub-questions a) and b) after each item of the scale. These answers will allow to determine if the formulation of the items is understandable by all, or if this is not the case, to identify the difficulties it can cause, and their causes.

Study Sites (1)

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